Circular 12/2013/tt-Byt: Instructions Detailing The Implementation Of A Number Of Articles Of Decree No. 96/2012/nd-Cp On November 15, 2012 Of The Government Regulations On The Treatment Of Addiction To The Drug Substance B

Original Language Title: Thông tư 12/2013/TT-BYT: Hướng dẫn chi tiết thi hành một số điều của Nghị định số 96/2012/NĐ-CP ngày 15 tháng 11 năm 2012 của Chính phủ quy định về điều trị nghiện các chất dạng thuốc phiện b

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
Circulars detailing the implementation of a number of articles of Decree No. 96/2012/ND-CP on November 15, 2012 of the Government regulations on the treatment of addiction to drug substances by alternative medicine _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to the law, against virus infection causing immunodeficiency syndrome made in people (HIV/AIDS);
Pursuant to Decree No. 96/2012/ND-CP on November 15, 2012 of the Government regulations on the treatment of addiction to drug substances by alternative medicine;
Pursuant to Decree No. 63/2012/ND-CP on August 31, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
At the suggestion of the Director of the Bureau of HIV/AIDS;
The Minister of Health issued a circular detailing the implementation of a number of articles of Decree No. 96/2012/ND-CP on November 15, 2012 of the Government regulations on the treatment of addiction to the drug substance with alternative medicine.
Chapter I GENERAL PROVISIONS article 1. Scope this circular guides on: 1. Operating conditions of the drug substance addiction treatment by alternative medicine (hereinafter referred to as the treatment facility).
2. Records, procedures, again operating licence with respect to the treatment facility.
3. procedure for suspension and revocation of activity licences for the treatment facility.
4. Guide the treatment register and forward the substance addiction treatment drug by alternative medicine.
Article 2. Principles of drug substance addiction treatment by alternative medicine 1. Drug substance addiction treatment by alternative medicine only made at the treatment facility are eligible under the provisions of this circular.
2. In compliance with the professional guidance of drug substance addiction treatment by alternative medicine as prescribed by the Minister of health.
Chapter II CONDITIONS of OPERATION of the TREATMENT FACILITY section 1 CONDITIONS of OPERATION of the TREATMENT FACILITY REPLACED Conditions 3. Conditions on campus in addition to satisfying the conditions specified in paragraph 1 article 12 of Decree 96/2012/ND-CP on November 15, 2012 of the Government regulations on the treatment of addiction to drug substances using alternative medicine (hereinafter referred to as the Decree No. 96/2012/ND-CP) alternative treatment facility must meet the following conditions: 1. The room of alternative treatment facility to be built for sure, enough light, dust ceiling, wall and floor materials easy to use cleaning solvents for cleaning, there are doors, Windows and certainly has the lock.
2. The lab must meet the following conditions: a) the wall of the test area, the test must be flat, waterproof, resistant to heat and corrosive chemicals;
b) Have water hand washing sinks, faucets, emergency eye wash box.
Article 4. The condition of the equipment 1. The room allocation and storage of drugs: a Wet design);
b) thermometer for measuring the temperature in the room;
c) conditioners;
d) 2 cabinets with locks, including: 4 cabinets to contain smoking daily allocation and storage cabinets for 1st;
medications and instruments);
e) Cabinets or shelves, profile books, treatment tracking votes.
2. The doctor: a thermometer to measure body temperature);
b) stethoscopes;
c) emergency medicine cabinet (including antidote);
d) sphygmomanometer;
DD) emergency equipment;
e) ambulance and Stretcher trolleys;
g) Patient Beds;
h) Weight measuring health-height.
3. Laboratory: a) urine test kits and blood;
b) refrigerator preserve, swabs.
4. Where to get the urine of the patient: a) The toilet (with water supply lines have van placed outside the place took the urine);
b) bulkheads stained glass paste a pm from the outside to the staff of the treatment facility to observe the process of self-urine samples of sick people.
5. other equipment consistent with the functions and duties of each room.
Article 5. Conditions of personnel in addition to satisfying the conditions specified in paragraph 3 article 12 of Decree 96/2012/ND-CP, alternative treatment facility to meet more of the following conditions: 1. The doctor has at least 3 employees had intermediate medical back-up, in which at least 12 doctors in charge of technical expertise has time to do consultation work disease, healing from 18 months or more.
2. allocate and preserve drugs at least 2 employees have specialized pharmaceutical intermediate or intermediate medical back-up, in which staff on duty to preserve the drugs must have qualified from secondary specialized pharmacy.
3. consulting Room with at least 1 staff having specialized pharmaceutical intermediate or intermediate medical or social specialisation level back up.
4. The lab has at least 1 staff level in one of the disciplines of medicine, pharmacy, biology or chemistry.
5. the Administration has at least 12 employees had intermediate or above.
6. There are at least 2 security guards.
Item 2 ACTIVITIES of FOUNDATIONS ALLOCATE SMOKING article 6. Conditions on campus in addition to satisfying the conditions specified in paragraph 1 article 13 of Decree 96/2012/ND-CP, base medications have to meet additional conditions specified in paragraph 1 of article 3 of this circular.
Article 7. The condition of the equipment meets the conditions specified in clause 1 4 of this circular.
Article 8. Conditions of personnel in addition to satisfying the conditions specified in paragraph 3 of the article 13 of Decree 96/2012/ND-CP, base medications have to meet additional conditions specified in clause 2 and Clause 6 article 5 of this circular.
Chapter III PROCEDURES, RECORDS, REISSUED the LICENSE WORKS for BASE TREATMENT of article 9. The records suggest, again operating licence with respect to the treatment facility 1. Records suggest active license for treatment facilities include: a) petition to license works the form prescribed in annex 1 attached herewith;
b) has decided to set up a certificate of competent State agencies or certified copies of business registration certificate or certified copies of certificates of investment;
c) list of treatment facility according to the form prescribed in Appendix 2 attached to this circular and enclosed copies are certified professional qualification of each employee in the treatment facility;
d) of the treatment facility;
DD) equipment Declaration of treatment facility according to the form prescribed in Appendix 3 attached to this circular.
2. the recommended records re-issued the license works for treatment facility permit lost or damaged works license include: a) petition according to the form prescribed in annex 1 attached herewith;
b) the original operating licence is damaged (if any);
c) activity reports of 6 months up to suggest active license again.
3. recommended records re-issued the license works for treatment facility changes location works, treatment facility operating license revoked: a) The documents prescribed in paragraph 1 of this article;
b) activity reports of 6 months up to suggest active license again.
Article 10. Procedures Refresh Active license for the treatment facility 1. The records suggest, again operating licence with respect to the treatment facility was established as 1 and sent to the provincial health department, central cities (hereinafter referred to as the Department) where treatment facilities are located.
2. Order and consider grant proposals, again operating licence with respect to the treatment facility: a) after getting the records suggest, again operating licence, the Department of health sent to the treatment facility grant proposal, again receiving Votes works license records according to the form prescribed in Appendix 3 attached to this circular;
b) during the period of 20 working days from the date of receipt of a valid application, Director of the provincial health department to organize the evaluation to level, again operating licence;
c) case records suggest, again not a valid activity licence then during 10 working days from the date of receiving the votes recorded on the record, the Health Department must inform in writing grant proposals, base reissuing permits operations to add or complete a profile. Written notice must be stated in specific content, the document need additional amendments;
d) upon receiving written request complete record, suggested base reissuing levels of active license to modify, complement the correct content was noted in the written notice and sent to the provincial health department. On receiving the additional profile, modify the receiving Votes be recorded on the record;
DD) base case suggest granting license to operate again, supplemented, modified the profile but not the right to require the Department of health, notice in writing to the recommended level, base reissuing permits operations to continue to complete the profile according to the provisions in point c of Paragraph 2 of this Article.
Article 11. Evaluation organization to grant, again operating licence with respect to the treatment facility provincial health department Director established mission to level, again operating licence with respect to the treatment facility with the following components: 1. Represent the Health Department leadership as head of the delegation.
2. the representative of the central leadership, HIV/AIDS the Chief Deputy Permanent delegate.
3. Representatives in the room was assigned to Operations Manager drug substance addiction treatment by alternative medicine-the Health Department as Deputy Head of the delegation.
4. Pharmaceutical Services Division-Department of health-province members.
5. experienced doctors about alternative treatment-members.
6. The representative-members.
7. The room was assigned to Operations Manager drug substance addiction treatment by alternative medicine-the Health Department Secretary mission.
Article 12. Level assessment process, again operating licence with respect to the treatment facility 1. Licensing assessment process works for treatment, base reissuing license works for base case treated location change works or revoked license to operate: a) due diligence legal records; check the conditions of the facilities, equipment, medical instruments, personnel of the treatment facility;
b) Established assessment thereon according to the form prescribed in annex 5 attached to this circular. Report on the evaluation of treatment facility was made into a 2:1 a save in the Department of health, 1 a save at the treatment facility be appraised;

c) during 2 working days from the date of the evaluation, the Evaluation Group to the Director of the Department of health evaluation thereon;
d) during 3 working days from receiving the report on the evaluation, the Department of Health Director must consider, decide, again operating licence with respect to the treatment facility. The case does not permit the operation must reply in writing and stating the reason.
2. assessment process to license works for treatment facility permit lost or damaged works permit include: a) during 5 working days from the date of receiving the recommended records re-issued the license works (the time of receipt by the receiving Office to mark of the Department of health) rooms are assigned to active management of drug substance addiction treatment by alternative medicine of the Department of health to examine the evaluation profile was granted a license to operate the facility the earlier treatment in the Department of health;
b) during 10 working days from the date of receiving the recommended records re-issued the license works (the time of receipt by the receiving Office to mark of the Health Department of the province), Director of the provincial health department to consider, decide the grant of operating licences again. The case does not permit the operation must reply in writing and stating the reason.
Article 13. Active license management 1. Each treatment facility is only granted a license to operate according to the form prescribed in annex 6 attached to this circular.
2. Copy the license works and records suggest, again operating licence are stored at the provincial health department.
Chapter IV PROCEDURE for SUSPENSION, REVOCATION of LICENSE to OPERATE for TREATMENT FACILITIES article 14. The case suspended the license of operation treatment facility suspended activities in the following cases: 1. Do not comply with the treatment process or have professional flaws under professional guidance due to the Minister of health.
2. The facilities, equipment and personnel does not guarantee the conditions as prescribed in this circular.
3. Do not carry the report on the situation and comply with the treatment of the sick person to the competent authority according to the regulations.
Article 15. Procedures, time suspended operations 1. During the inspection, the inspection activities of the treatment facility if the discovery that had treatment facilities in violation of the provisions of article 14 of this circular, the unit performs the check, the inspector must report on the temporary suspension of activities according to the form prescribed in annex 6 attached to this circular and posted on the Department of health.
2. In time of 5 working days from the date of the report on the temporary suspension of activities specified in paragraph 1 of this article, the Director of the Department of health consideration, decide the suspension of activities. The decision to suspend activities that the time limit must not exceed 6 months from the date signed, issued and sent to the treatment facility suspended activities, the Center for prevention of HIV/AIDS in the province.
3. where the treatment facility were suspended undertook work to remedy the breach then the slowest is 30 days before the date of expiry of the suspension decision, treatment facility suspended activities must submit a report on the redress of the violation to the Department of health of the province where the treatment facility suspended operations headquarters. The time of receipt of the report to fix the violation by the reception to mark of the provincial health department.
4. In time of 5 working days from the date of the report on the remedy the breach of the base is suspended, the provincial health department to proceed with the appointment of the unit performs the test of recovery treatment facility (hereinafter referred to as the specified unit).
5. During 10 working days from the date of receipt of the Health Department, the unit was assigned to conduct the inspection and report the results of the medical examination. The time of receipt of the text specified by the receiving Office to mark of the specified unit.
6. The base case suspended treatment have made the remedy the breach and meet the provisions of this circular, then during 5 working days from receipt of the report of the unit (the time of receipt of the report to fix the violation by the reception to mark of the Department of health) , Director of the Health Department must consider, decide the termination of operations. The decision to terminate the suspension of the works sent to the treatment facility suspended activities, the Center for prevention of HIV/AIDS in the province.
7. in case of expiry of suspension which suspended treatment facilities failing to remedy the breach or have done work to remedy the breach but still does not meet the provisions of this circular, then during 5 working days from the date of the expiration of the suspension decision or from the date of receiving the reports of the unit are specified , Director of the Health Department of the province to review the decision to terminate the operation of the treatment facility.
Article 16. Revoke the operating licence of the treatment facility operating licence revoked in the following cases: 1. Operating licence granted vires.
2. After 12 months from the date of the activity licence which the treatment facility is not active.
3. Treatment Facility to pause operation during the 12 consecutive months or has terminated operations.
4. Change of the location of the treatment facility.
5. where the provisions of Clause 7 article 15 of this circular.
Article 17. Procedure for revocation of the license of operation of the treatment facility 1. During the inspection, the inspection activities of the treatment facility has been granted a license to operate, if the detection basis that in violation of the provisions of article 16 of this circular, the unit performs the inspection, the inspector must report on the temporary suspension of activities according to the form prescribed in annex 6 attached to this circular and posted on the Department of health the province.
2. In time of 5 working days from the date of the report on the temporary suspension of activities specified in paragraph 1 of this article, the Director of the Department of health to review the decision to revoke the activity licence. The decision to revoke the activity licence was sent to treatment facility operating license revoked, the Center for prevention of HIV/AIDS in the province.
Chapter V REGISTRATION INSTRUCTIONS to JOIN the ALTERNATIVE TREATMENT and FORWARD ALTERNATIVE TREATMENT Article 18. Register to join the drug substance addiction treatment for people addicted to the drug substance 1. Procedures, records registered to participate in drug substance addiction treatment for people addicted to the drug substance to comply with the provisions of Decree No. 96/2012/NĐ-CP dated. 2. Participation application form drug substance addiction treatment follow the form prescribed in annex 8 attached to this circular.
Article 19. Transition procedures quality addiction treatment drug 1. The procedure to transfer the drug substance addiction treatment: a) the sick apply transition recommended treatment according to the form prescribed in Appendix 3 attached to this circular for the head of the treatment facility where the person is taking treatment;
b) during 2 working days from the date of receiving the application forwards the patient's treatment, the head of the treatment facility where sick people have the aspiration to move responsibility to set the record copy and transfer to send the sick substance addiction treatment drug (hereinafter the transfer send) according to the form prescribed in annex 10 attached This circular;
c) during 2 working days, counting from the date of the record of sick people have the aspiration to be forward of the treatment, the new treatment facility is responsible for receiving and implementing the treatment for people moving to.
2. procedures for changing treatment facility: a) the sick apply transition recommended treatment according to the form prescribed in Appendix 3 attached to this circular for the head of the treatment facility where the person is taking treatment;
b) during 10 working days from the date of receiving the application forwards the patient's treatment, the head of the treatment facility where sick people have the aspiration to move responsibility to set the record copy and transfer to send the form prescribed in annex 10 attached herewith;
c) during 2 working days, counting from the date of the record of sick people have the aspiration to be forward of the treatment, the new treatment facility are responsible for receiving records and perform the treatment for people moving to.
Chapter VI article 20 IMPLEMENTATION RESPONSIBILITIES. The responsibility of the Ministry of health 1. Steer, guide, inspect, inspect the implementation of this circular all around the country.
2. In cooperation with the relevant units to build the program, training materials on alternative treatment; research, science and technology applications in the alternative treatment.
3. implementation of expert cooperation, transfer of technology and new methods of treatment, the other international cooperation activities of alternative treatment.
Article 21. The responsibility of the Department of health of the province of 1. Hosted, in cooperation with other departments, branches and units involved in building and the provincial people's Committee approved the project in local alternative treatment as prescribed by law.
2. Direction, guide, inspect, inspect the implementation of this circular on management.
3. Manage the licensing activities for the local treatment facility; publicizing the data related to the provision of, again, the list of treatment facility has been granted, issued, suspended or revoked operating licence on the website of the Department of health.
4. Inspect, monitor the operation of the treatment facility under the control of management; testing, inspection and handling of violations related to the deployment of alternative therapeutic activities on geographical as defined by law.
5. Make the report mode, the level again and recover the operating licence for the treatment facility under the provisions of the law.
Article 22. The responsibilities of the Centre, the HIV/AIDS 1. Chief of the Department of health for the overall construction project on the deployment of alternative treatment locally.
2. The guide, technical support for the deployment of alternative treatments for the treatment facility in charge under the provisions of the law.

3. Join the examination, monitor the operation of the treatment facility under the control of management.
Article 23. Responsible of the treatment facility 1. Organized drug substance addiction treatment by alternative medicine as instructed by the Minister of health regulations.
2. additional infrastructure, equipment and human resources consistent with the needs of the work in the base case alternative treatment have patient numbers in excess of 250 people, the basis of the number of medications a patient in excess of 100 people.
3. monthly periodic report list of people to be treated, the treatment situation and comply with the treatment of the object taking alternative treatment for the competent organ as specified.
4. Subject to the checking, monitoring of the Health Department and the Center for HIV/AIDS in the province.
Chapter VII ENFORCEMENT PROVISIONS article 24. Terms of reference case reference texts in this circular are replaced or modified, supplemented the following replacement text or text was amended and supplemented.
Article 25. Effective enforcement of this circular effect since June 1, 2013.
Article 26. Transitional provisions 1. The treatment facility construction new or renovated after the date of this circular effect must satisfy the conditions prescribed in this circular.
2. The treatment facility already operating before 1 January 2013 to be continued but slow to 30 July 2014 must send the proposal active license as specified in paragraph 1 article 9 of this circular to implement licensing procedure works.
Article 27. Responsibility Director, HIV/AIDS, Director of Legal Affairs and Chief Inspector of the Ministry within the scope of the functions, duties, and powers was given the responsibility to coordinate with the Service, Bureau, the Directorate concerned inspect, inspect the level, active license again, making drug substance addiction treatment by alternative medicine and the observance of the law of the treatment facility within the country.
In the process, if there are obstacles, the proposal reflects the timeliness of the Ministry of health (HIV/AIDS) to the research, resolve./.